BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993017 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09523
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT, WHILE BENDING OVER, THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AGAIN. AN INTERROGATION SHOWED THAT THE SHOCKS WERE DUE TO T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE ON THE RV LEAD. IT WAS NOTED THAT SENSITIVITY WAS PREVIOUSLY ADJUSTED FOR A SIMILAR EXPERIENCE OF SHOCKS RELATED TO TWOS. THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED FOR T-WAVE OVERSENSING. REPROGRAMMING WAS PERFORMED AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472607 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Life Threatening| R (B)(4) ICD